K252658
- 510(k) number
- K252658
- Device name
- Medical Diode Laser Systems (TR-B)
- Applicant
- Baoding Te'Anzhou Electronic Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-28
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252658.pdf
Official FDA record: K252658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.